Senior Medical Writer

🕒 September 30

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 14%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 46 days.
• Jobs at this company usually fill in 34 days.
• No salary listed.

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TransPerfect

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

Consulting • Legal • Marketing

TransPerfect is a global language and technology company that provides translation, localization, interpretation, and content services combined with software and AI-powered tools such as the GlobalLink translation management platform. It offers multilingual marketing, legal and life‑sciences regulatory support, contact center/BPO services, multimedia localization, and solutions for website, software and app globalization. TransPerfect serves large enterprise and Fortune 500 clients across dozens of industries and supports content in 200+ languages.

📋 Description

• Lead planning and preparation of high-quality clinical regulatory documents • Produce protocols, publications, study reports, investigator brochures, narratives, and module documents • Lead document execution and project management tasks, including creating, maintaining, and communicating timelines • Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing • Ensure document development follows client processes, templates, and instructional documents • Serve as an expert on client document management systems, tools, templates, and procedures • Lead document message development with clients • Interpret data and create shell documents to support authoring • Plan and lead kickoff meetings • Facilitate review feedback resolution and lead comment resolution meetings • Follow up with team members to resolve outstanding review feedback • Ensure consistency in messaging, formatting, and presentation across client programs • Conduct literature searches as needed • Perform peer quality-control review as needed • Contribute to medical writing operational initiatives such as templates, style guides, and reference management

🎯 Requirements

• 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field • Bachelor’s degree or higher in a relevant field • Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents • Flexibility to work across multiple therapeutic areas • Experience writing documents according to established processes and document templates • Familiarity with lean authoring approaches and structured content management • Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired • Expertise with Microsoft Word and other Microsoft applications • Experience with document management systems, collaborative authoring tools, and review tools • Ability to adapt to new tools and technologies • Ability to work independently and collaboratively amid competing priorities • Service-oriented and proactive approach to project management • Conflict management and negotiation skills • Strong written and verbal communication skills • Oncology, Infectious Disease, or Vaccine experience desired

🏖️ Benefits

• Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law

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